Abbott (NYSE:ABT) announced today that the FDA has approved its low-dose, recharge-free spinal cord stimulation system with up to 10-year battery life for people in chronic pain.
The Proclaim XR neurostimulation system couples low-energy therapy with a low-dosing protocol to provide pain relief and preserve its battery.
Abbott said its BurstDR stimulation waveform was designed to mimic natural patterns found in the brain and to use low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. The low doses extend the system’s battery life, the company said.
Proclaim XR also uses Apple mobile devices and Bluetooth wireless technology.
Abbott developed the system based on positive results from a study that showed all 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of battery use per day, while approximately half of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use per day). Even at the highest settings, the systems were still in use only 25% of the time, the company noted. Data from this trial were presented at multiple medical society meetings, including the North American Neuromodulation Society (NANS) and the International Neuromodulation Society (INS) earlier this year.
“For the 50 million people living with chronic pain in the United States, this is a new and exciting treatment that is supported with evidence validated by the BOLD study, an established protocol for titrated intermittent dosing to give patients individualized pain relief while using therapy for six hours or less per day,” said Dr. Timothy Deer, president & CEO of The Spine and Nerve Center of the Virginias in Charleston, W.Va., in a news release. “Proclaim XR is a major advancement in spinal cord stimulation and is an evidence-based therapy that is mobile app-based and features upgradeable software. This means patients won’t need surgery to benefit from future advances in this technology.”
“Proclaim XR is the latest advancement in patient-centric pain therapy — opening the doors for people who don’t want to be burdened with the hassles of recharging. Recharge-free means patients can live their lives without the constant reminder of being in treatment,” said Keith Boettiger, vice president of Abbott’s neuromodulation business. “This is a meaningful advancement for the millions of people who need new options when it comes to managing the effects of their chronic pain. Abbott is committed to developing life-changing solutions and putting the patient at the center of everything we do.”
Proclaim XR is currently under review for CE Mark.